PENTRON FibreKor Fiber Post Instruction Manual

FibreKor Fiber Post
Instruction Manual

FibreKor Fiber Post

Instructions for Use – FibreKor

PART NUMBER| DMC3277
REVISION| 1
REVISION DATE| 2021-09
|
BINDING| Cuted
CORNER| N/A
COLORS| 1/1, Black
SIZE| 44 x 98 cm, folded dimension 7 x 14 cm
PAGE COUNT| 4 pages front and back / 2 pieces
MATERIAL| 40 g/m2 Pharmathinprint
ADHESIVE MATERIAL| N/A
COATING| Folded, with perforated wafer seal
DIELINE| Blueline Does Not Print

FibreKorm Fiber Post

GENERAL INFORMATION

FibreKor Posts feature longitudinal glass fibers bundled in a resin matrix designed to deliver strength, flexural modulus, and esthetics. FibreKor Posts are available in a kit or refills in a variety of sizes.

PRODUCT COMPOSITION
FibreKor is a methacrylate resin based glass fiber post.

INDICATIONS FOR USE
Reinforcement of an end odontically involved tooth. Retention of core and core material.

CONTRAINDICATIONS
None known.

WARNINGS

• FibreKor posts should NOT be used in teeth with less than 2 mm of corona! tooth structure above the crestal bone.
• FibreKor posts must NOT be cemented with glass ionomer, zinc phosphate or polycarboxylate cement.
• FibreKor drills should not be used on patients with known sensitivity to chromium.
• FibreKor drills must be sterilized via steam autoclaving prior to use. See the cleaning and sterilization instructions below.
• FibreKor posts must be disinfected. 70% isopropyl alcohol may be used. Following disinfection, thoroughly rinse and dry the post before cementing.
• Do not use FibreKor drills at higher than 1,000 RPM.

PRECAUTIONS

• This product is intended to be used by qualified dental professionals on a general patient population.
• Use a rubber dam to isolate the treated tooth and avoid fluid contamination during the procedure.
• If 2 mm of coronal tooth structure above the (testa’ bone is unavailable, crown lengthening or orthodontic forced eruption should be considered to achieve an adequate ferrule.
• FibreKor posts are pre-silanated for increased adhesion to resin cements and core
• To minimize stress on the core-tooth interface and the post contained within, the finish line or margin of the preparation should remain on the solid tooth structure, not on the core buildup.
• FibreKor posts must be cut with a diamond bur. Do not cut fiber posts with a carbide bur as this may splinter the post.
• If endodontic retreatment of the apex is required, the FibreKor post can be removed by drilling into the center of the post with a needle diamond to a depth of 2-3 mm to start, then continue with the corresponding size of FibreKor drill. It is recommended that during post removal, frequent radiographs be taken to ensure that the instruments are following the path of the post to help prevent perforation of the root
• FibreKor posts, tips and applicator brushes are for single patient use only. This is to prevent cross-contamination between patients.

ADVERSE EVENTS

If a serious incident occurs with this medical device, report it to the manufacturer and to the competent authority for that country in which the user and/or patient is established.

STEP-BY-STEPINSTRUCTIONS

1. Isolate the treated tooth with a rubber dam.
2. Estimate the width and depth of the post space preparation based on the dinica I examination and the radiograph of the treated tooth. Refer to the table at the end of this section for available sizes of posts and corresponding drills.
3. Select a post with a diameter that is similar in diameter of the obturated canal at the tooth’s cervical to ensure as much cervical tooth structure as possible is preserved.
4. Determine the depth of the post space preparation, leaving at least 4 mm of obtu ration material or g utta-percha at the apical end. Place rubber endodontic stop on the drill corresponding to the desired depth to avoid overpreparing the post space.
5. Alternatively, use a heated instrument to remove the obturation material followed by a post drill that was previously selected.
6. Using the size of FibreKor drill that matches the post to be inserted, complete the canal preparation.
7. Flush out the canal to remove the debris and dry it with an air syringe and paper points
8. Trial seat the FibreKor post in the canal that corresponds to the size of the drill used. A radiograph may be taken at this point to verify that the post is fullyseated.
9. FibreKor Posts must be trimmed with a water-cooled, high-speed diamond bur. Rotate the post while cutting to ensure a smooth cut.
10. Clean the post with an alcohol wipe and dry it with a blast of oil-free air.
11. Cement the post using your preferred cement material according to manufacturer’s instructions.

FibreKor Posts & Drills

Picture| Post| Drill
| 1.00 mm (red)| 1.00 mm (red)
| 1.125 mm (purple)| 1.125 mm (purple)
1.25 mm (yellow)| 1.25 mm (yellow)
1.375 mm (green)| 1.375 mm (green)
1.50 mm (blue)| 1.50 mm (blue)
Due to its size, the 1.00 mm post is not serrated.

CLEANING. DISINFECTION AND STERILIZATION

DISINFECTION INSTRUCTIONS FOR FIBREKOR POSTS

FibreKor posts must be disinfected. 70% isopropyl alcohol may be used. Following disinfection, thoroughly rinse and dry the post before cementing.

CLEANING AND STERILIZATION INSTRUCTIONS FOR POST DRILLS Thorough cleaning is an essential pre-requisite for effective sterilization. Clean the

post drills immediately after each patient use following the cleaning steps to prevent drying of soil and contaminants.

Cleaning:

1. Remove from the post drill any debris or organic matter with a 70% isopropyl alcohol disposable wipe. Wipe until no visible soil remains on the post drill.

2. Inspect drills for scratches, deformations, oxidation or discoloration prior or after Discard if it does not pass inspection.

3. Immediately soak in an ultrasonic unit in accordance with the ultrasonic unit manufacturer’s instructions for a minimum of 5 minutes.

4. Rinse with water and dry instruments with a soft clean cloth and place in a sterilization pouch for steam sterilization following the instructions of the pouch manufacturer. Ensure that sterilization pouches comply with national requirements such as ISO 11607-1 and for USA use FDA-cleared accessories.
   Sterilization:
   Steam autoclave, gravity displacement. 134°C (274°F) for 10 minutes, dry fora minimum of 30 minutes.
   OR
   Steam autoclave, pre-vacuum. 132°C (270°F) for 4 minutes, dry for a minimum of 16 minutes. Do not use chemical autodave or cold sterilization solutions.

5. When the product is taken out of the autoclave, check the sterilization pouch for any damage. In case of a perforated pouch, do not use the product, as the sterilization could be compromised. Re-pack the product and repeat the sterilization procedure.

6. After sterilization, place the pouches containing the drill in a dry and dust free Follow the instructions provided by the pouch manufacturer regarding storage conditions and maximum allowed time in storage.

Mall! e instructions provided in the section “Cleaning and Steri cation Instructions” have been validated byt he manufacturer of the medical device as being capable of preparing a medical device for reuse. Health care fadlities are responsible for making sure that the sterilization equipment is calibrated according to the manufacturer’s manuals and specifications. In addition, health care facilities are responsible for trailing their staff on infection control, proper sterilization, deaning and disinfection  procedures.

STORAGE AND DISPOSAL

FibreKleer 4x post should be stored between 2°C to 25°C (36°F to 77°F). Allow the product to reach room temperature prior to use.The expiration date is marked on packaging. Do not use FibreKleer 4x post afterexpiration date. For proper disposal always follow your local and national regulations.

LIMN EU WAHHANIY—LIMITATION OF PIN I RUN’S LIABILITY

Pentron’s technical advice, whether verbal or in writing, is designed to assist dentists in using Pennon’s product. The dentist assumes all risk and liability for damages arising out of the improper use of Pentron’s product In the event of a defect in material or workmanship, Pentron’s liability is limited, at Pentron’s option, to replacement of the defective product or part thereof, or reimbursement of the actual cost of the defective product. In order to take advantage of this limited warranty, the defective product must be returned to Pentron. In no event shall Pentron be liable for any indirect inddental, or consequential damages.

EXCEPT AS EXPRESSLY PROVIDED ABOVE, THERE ARE NO WARRANTIES, BY PENTRON, EXPRESS OR IMPLIED, INCLUDING WARRANTIES WITH RESPECT TO DESCRIPTION, QUALITY, OR FITNESS FOR A PARTICULAR PURPOSE

SYMBOLS DESCRIPTION

Full explanation of symbols used on Pentron packaging is looted at:
http://www.pentron.com/symbols-g lossary

Documents / Resources

| PENTRON FibreKor Fiber Post [pdf] Instruction Manual
FibreKor, Fiber Post, FibreKor Fiber Post
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